BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22

    MDR report key: 25031564 · Received April 29, 2026

    Report

    Report Number
    6000034-2026-01565
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 29, 2026
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P890027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PER THE CLINIC, IN (B)(6) 2026 (SPECIFIC DATE NOT REPORTED), THE PATIENT BEGAN EXPERIENCING INTERMITTENT SOUND DROPOUTS. THE DURATION AND FREQUENCY OF THESE SOUND INTERRUPTIONS GRADUALLY INCREASED OVER TIME. HARDWARE EXCHANGE ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. AT A LATER STAGE, COMMUNICATION WAS SOMETIMES TEMPORARILY RECOVERED WHEN STRONGER PRESSURE WAS APPLIED TO THE MAGNET; HOWEVER, THIS WAS INCONSISTENT AND OFTEN INEFFECTIVE. ON MARCH 16, 2026, THE PATIENT EVENTUALLY LOST ALL SOUND COMPLETELY, AND NO COMMUNICATION WAS POSSIBLE. UPON CONNECTING TO THE SOFTWARE, NO SOUND PERCEPTION WAS OBTAINED, WITH NO DISCOMFORT REPORTED. THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401682 NUCLEUS 22 NUCLEUS 22 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other